Bicycle Therapeutics Announces First Patient Dosed in Phase IIa Trial of Bicycle® Toxin Conjugate BT1718

On September 2, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that the first patient has been dosed in the Phase IIa expansion portion of the Phase I/IIa trial sponsored by Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research (Press release, Bicycle Therapeutics, SEP 2, 2020, View Source [SID1234564268]). The trial is evaluating BT1718 in patients with MT1-MMP-positive squamous non-small cell lung cancer (NSCLC) and a basket of other MT1-MMP-positive solid tumors.

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"With the Phase IIa expansion, we look forward to building on the encouraging data generated through the Phase I dose escalation, in which BT1718 appeared tolerable with manageable adverse events and preliminary signs of anti-tumor activity were observed," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "BT1718 is a Bicycle Toxin Conjugate, or BTC, that targets the antigen MT1-MMP, which was observed in our translational research to be highly expressed on the membrane of tumors of a squamous cell origin. Squamous NSCLC represents a key patient segment where there is a high unmet need for new treatment options, given the limitations of current therapies. We believe BT1718 represents a potential first-in-class therapy that could have significant potential in the treatment of squamous NSCLC, as well as more broadly across other MT1-MMP-expressing cancers with high unmet need."

BT1718 is a BTC targeting MT1-MMP and is comprised of a mono-hindered disulfide cleavable linker and a cytotoxic DM1 payload. The Phase IIa expansion will evaluate BT1718 administered once weekly at the recommended Phase II dose (RP2D) of 20 mg/m2 in an MT1-MMP-positive squamous NSCLC cohort, as well as in an MT1-MMP-positive solid tumor "basket" cohort. For the first time in the Phase I/IIa trial, patients will be preselected based on levels of antigen expression in target lesions, as determined by the Company’s proprietary clinical-grade MT1-MMP immunohistochemistry (IHC) assay. The primary objectives of the Phase IIa expansion portion are to evaluate the safety and tolerability profiles of BT1718. One of the secondary objectives is to assess anti-tumor response, as measured by RECIST criteria. The trial is sponsored by Cancer Research UK’s Centre for Drug Development and will be conducted at sites in the UK.

Dr. Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "We’re delighted to be sponsoring this Phase IIa trial of BT1718. Looking to the future, we believe BT1718 has the potential to create an entirely new treatment option for people with non-small cell lung cancer and other solid cancers whose therapeutic need is unaddressed by current medicines."

Syndax Announces Participation at Three Upcoming Investor Conferences

On September 2, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that members of its management team will participate in three upcoming virtual investor conferences. The details for the three conferences are (Press release, Syndax, SEP 2, 2020, View Source [SID1234564267]):

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Citi 15th Annual BioPharma Virtual Conference on Wednesday, September 9, 2020. Panel at 11:40 a.m. ET.
Baird 2020 Virtual Global Healthcare Conference on Thursday, September 10, 2020. Fireside chat at 4:20 p.m. ET.
Morgan Stanley 18th Annual Global Virtual Healthcare Conference on Monday, September 14, 2020. Fireside chat at 2:15 p.m. ET.
A live webcast of the events can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

Placing to raise £6.5 million

On September 2, 2020 ImmuPharma plc (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, reported that in response to investor demand, it has raised £6.5 million, before expenses, via an oversubscribed Placing of 59,090,909 new ordinary shares of 10p each in the Company ("Ordinary Shares") at a price of 11p ("Placing Price") per share (the "Placing Shares") with investors (the "Placing") (Press release, ImmuPharma, SEP 2, 2020, View Source [SID1234564266]).

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Placing Shares and Admission

The Placing Shares will be issued credited as fully paid and will rank pari passu in all respects with the Company’s existing issued Ordinary Shares.

An application will be made for the Placing Shares to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") and Euronext Growth Brussels ("Admission"). It is anticipated that Admission to AIM will occur at 8.00am on or around 7 September 2020. The Placing is conditional, among other things, upon Admission to AIM becoming effective and the placing agreement (entered into between the Company, Stanford Capital Partners Limited ("SCP"), SI Capital Limited ("SI") and SPARK Advisory Partners Limited ("SPARK") today) not being terminated in accordance with its terms.

The Placing Shares represent 24.3% of the Company’s enlarged issued share capital. The Placing Price represents a 27.6% discount to the 7 day volume weighted average price of the Company’s shares on AIM on 1 September 2020.

Issue of Warrants

In connection with their services in relation to the Placing, the Company has issued warrants over 1,213,920 Ordinary Shares with an exercise price of 11p per share to SCP and issued warrants over 1,213,920 Ordinary Shares with an exercise price of 11p per share to SI. These warrants have an exercise period expiring on the 10th anniversary of Admission.

Adjustment to the CSD and Options of L1 and Lind

As notified on 11 June 2020, the Company entered into a convertible security deed ("CSD") and option deed ("OD") dated 10 June 2020 with each of L1 Capital Global Opportunities Master Fund ("L1") and Lind Global Macro Fund, LP ("Lind").

Pursuant to the terms of the CSD, each of Lind and L1 have the right to require the Company, as a consequence of the Placing, to repurchase a portion of the convertible security in an amount equal to, in aggregate, up to 25 per cent of the gross proceeds of the Placing (being £1,625,000, which will be converted into US dollars at the time of conversion in accordance with the CSD).

Under the terms of the CSD, the Company is required to give Lind and L1 notice of the Placing within 10 calendar days of Admission. If either Lind or L1 wish to exercise their right to require repayment of a portion of their convertible security, they must give notice to the Company no later than 13 calendar days after the date of notice from the Company. No indication has been given by Lind or L1 whether they intend to exercise this right.

As a consequence of the Placing (i) the conversion price stated in the CSD (previously 17.96p) will be adjusted downwards to the Placing Price meaning that, upon conversion in full of the CSD, 21,369,354 new Ordinary Shares (subject to adjustment at the time of conversion by reference to the sterling – US dollar exchange rate at the time) would be issued in aggregate to L1 and Lind (compared to 13,086,619 previously); and (ii) under the OD, both the option exercise price and the number of shares subject to the options will vary. In aggregate, following the Placing, 25,640,254 Ordinary Shares (compared to 15,703,942 previously) will be subject to the OD at an option exercise price of 11p per share.

Lind and L1 have not exercised their right of participation in the Placing.

Lanstead Capital Investors LLP ("Lanstead")

There will be no changes or amendments to the two existing Sharing Agreements with Lanstead as a result of the Placing.

Issue of shares to Allele Capital Partners ("Allele")

As notified in the announcement on 11 June 2020 the Company has now entered into a Strategic Advisory Agreement with Allele. Under that agreement the Company has, on 1 September 2020, allotted to Allele 682,242 new Ordinary Shares at an agreed issue price of 16.57p per share.

Total Shares in Issue

For the purposes of the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority ("DTR"), the Board of ImmuPharma hereby notifies the market that following Admission, the Company’s total issued share capital will consist of 242,784,071 Ordinary Shares with a nominal value of 10p each per share.

This figure may be used by Shareholders as the denominator for the calculations by which they may determine if they are required to notify their interest in, or a change to their interest in the Company under the DTR.

The allotment of the Placing Shares is being made pursuant to existing authorities to allot shares and other relevant securities and to disapply pre-emption rights under section 551 of the Companies Act 2006, which the Directors were given at the Company’s Annual General Meeting held on 18 June 2020.

Use of Proceeds

The proceeds from the Placing, net of fees and expenses, are expected to be approximately £5.9 million and will be used to progress the Company’s therapeutic pipeline including one of its new developments, BioAMP-B, a novel peptide-based drug that offers a potential treatment for many serious and life threatening fungal infections such as aspergillosis (lung infection). Funds will also provide the Company with additional working capital.

Taking into account existing cash resources and the expected net proceeds, the Company expects to have sufficient cash resources to fund operations through the end of 2023.

The Placing was undertaken by ImmuPharma’s joint brokers, Stanford Capital Partners and SI Capital.

Tim McCarthy, ImmuPharma’s Chairman said: "In response to strong investor demand, this successful and over-subscribed fundraising has brought together new and returning institutional investors, with existing and new private investors. With a strong balance sheet, a diverse and exciting therapeutic pipeline and our lead drug candidate, Lupuzor moving forward into an international Phase III trial, ImmuPharma is in an extremely robust position. With value enhancing news-flow over the next period, we are confident of creating long term shareholder value for all of our shareholders."

Bristol Myers Squibb to Participate in Citi’s 15th Annual BioPharma Virtual Conference

On September 2, 2020 Bristol Myers Squibb (NYSE: BMY) reported that the company will take part in a fireside chat at Citi’s 15th Annual BioPharma Virtual Conference, which will be webcast on Tuesday, September 8, 2020 (Press release, Bristol-Myers Squibb, SEP 2, 2020, View Source [SID1234564265]). Samit Hirawat, MD, EVP, Chief Medical Officer and Rupert Vessey, MA, BM BCh, FRCP, DPhil, EVP of Research and Early Development will answer questions about the company at 12:15 p.m. EDT.

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

Targovax is invited to present at Pareto Nordic Healthcare conference and RAS-targeted drug development summit

On September 2, 2020 Targovax ASA, reported that members of its senior management team is invited to present at upcoming conferences (Press release, Targovax, SEP 2, 2020, View Source [SID1234564242]).

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Pareto Securities’ 11th Annual Health Care Conference 2020, virtual
Date: 2 September 2020
Presenter: Torbjørn Furuseth (CFO)

Presentation:
– Time: 11:30 CET

2nd Annual RAS-Targeted Drug development summit, virtual
Date: 15 September 2020
Presenter: Erik Digman Wiklund (CBO)

Presentation:
Title: Adopting a Polyvalent Approach to Aid Development of Vaccines Against Mutant RAS
Time: 15:40 EDT / 21:40 CET

Panel discussion:
Live Q&A Panel
Time: 16:10 EDT / 22:10 CET

Presentations will be available to download at www.targovax.com after the event.